The Recall Desk

Hazard

Device Defect recalls

450 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
450
Critical
11
Severe
45
Most recent
2026-08-26

Of the 450 device defect recalls we have scored against our rubric, 11 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (10%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

251–275 of 450

  • HighFDA (Devices)·Z-0970-2020·2020-02-12

    Cook Inc. Recalls Urethral Dilation Balloon Catheters Due to Wire Guide Defect

    Cook Inc. is recalling 13,388 Urethral Dilation Balloon Catheters because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.

    Product
    Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2020·2020-02-12

    Cook Inc. Recalls Wire Guide Due to Incorrect Loading Risk

    Cook Inc. is recalling 13,388 Wire Guide units because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Wire Guide, Guidewire, Global Product Number G14326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2020·2020-02-12

    Cook Inc. Recalls Urethral Dilator Sets Due to Wire Guide Loading Error

    Cook Inc. is recalling Urethral Dilator Sets because the wire guide may load incorrectly, causing a stiff tip to be introduced into the patient instead of a flexible one.

    Product
    Urethral Dilator Set, Global Product No. G14185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2020·2020-02-12

    Cook Inc. Recalls C-Flex Double Pigtail Ureteral Stent Sets

    Cook Inc. is recalling C-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2020·2020-02-12

    Cook Inc. Recalls Kwart Retro-Inject Ureteral Stent Sets

    Cook Inc. is recalling Kwart Retro-Inject Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2020·2020-02-05

    ROi CPS Recalls Custom Procedure Packs Containing Recalled Clearlink Devices

    ROi CPS LLC is recalling 412 custom procedure packs containing Clearlink Continu-Flo devices that were previously recalled by Baxter Healthcare Corporation.

    Product
    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - M
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0902-2020·2020-02-05

    Haemonetics Recalls Cell Saver Elite Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling Cell Saver Elite Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete blood washing.

    Product
    JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling 739 Cell Saver bowl sets because cracks in the inner core can cause leaks and incomplete blood washing.

    Product
    JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2020·2020-02-05

    Haemonetics Recalls Cell Saver Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling 8,641 Cell Saver 5/5+ Fastpacks because cracks in the bowl core can trap fluid, causing incomplete washing and device errors.

    Product
    CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling Cell Saver 5/5+ Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete washing.

    Product
    CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2020·2020-02-05

    Haemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks

    Haemonetics is recalling CS Elite Processing Sets (125 ml) because cracks in the bowl core may cause fluid trapping and incomplete blood washing.

    Product
    CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0370-2020·2019-11-20

    Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

    Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

    Product
    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0200-2020·2019-11-06

    Ethicon Echelon Flex Endopath Stapler Recall for Out-of-Spec Anvil

    Ethicon is recalling Echelon Flex Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.

    Product
    ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2020·2019-10-16

    Centurion Medical Invasive Procedure Tray Recall for Connector Defect

    Centurion Medical Products is recalling Invasive Procedure Trays because they include a recalled connector that may release fluid droplets.

    Product
    INVASIVE PROCEDURE TRAY MNS9510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2020·2019-10-16

    Centurion Triple Lumen Bundle Kit Recalled for Fluid Droplet Risk

    Centurion Medical Products is recalling Triple Lumen Bundle Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    TRIPLE LUMEN BUNDLE KIT ECVC1540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0100-2020·2019-10-16

    Centurion Medical Products Recalls OR VANTEX Kits Due to Connector Defect

    Centurion Medical Products is recalling OR VANTEX kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate after disconnection.

    Product
    OR VANTEX 7FR 3L 16CM CVC ECVC6665
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2020·2019-10-16

    Centurion Medical Products Recalls Triple Lumen CVC Kits Due to Connector Defect

    Centurion Medical Products is recalling Triple Lumen CVC kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate from the sealed surface after disconnection.

    Product
    TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2020·2019-10-16

    Centurion Neonatal Procedure Tray Recall Due to Connector Fluid Droplet Risk

    Centurion Medical Products is recalling Neonatal Procedure Tray PICC Catheters because the included BD MaxZeroNeedleess Connector may release fluid droplets when disconnected.

    Product
    NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2020·2019-10-16

    Centurion Medical Recalls VANTEX CVC Bundles Due to Connector Defect

    Centurion Medical Products is recalling VANTEX 7FR, 16CM, 3L CVC Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.

    Product
    VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2020·2019-10-09

    Quality Electrodynamics Recalls 3 Siemens Knee Coils Due to Ferrous Material

    Quality Electrodynamics LLC is recalling three Siemens 1.5T Knee Coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2759-2019·2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 153 units of Triathlon Femoral Distal Augments because a device overhang issue causes them to protrude beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See att
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0038-2020·2019-10-02

    Natpara Injection Recall Issued for Potential Needle Clogging and Underdosing

    Shire is recalling Natpara (parathyroid hormone) for Injection due to a defective delivery system that may allow rubber stopper particles to clog the needle, leading to underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0036-2020·2019-10-02

    Natpara Injection Cartridges Recalled for Potential Needle Clogging

    Shire is recalling Natpara injection cartridges because rubber stopper particles may clog the needle, potentially causing underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0037-2020·2019-10-02

    Natpara Injection Cartridges Recalled for Potential Needle Clogging

    Shire is recalling Natpara (parathyroid hormone) injection cartridges because rubber stopper particles may clog the needle, leading to underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0035-2020·2019-10-02

    Natpara Injection Recall Due to Potential Needle Clogging and Underdosing

    Shire is recalling Natpara (parathyroid hormone) injections because rubber stopper particles may clog the needle, potentially causing underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
    Category
    Drug
    Distribution
    0 states